Vaping “Friends” Support the Nicopure/R2B Lawsuit

Amicus curiae briefs filed by SFATA and two think tanks


Friend of the court

The judge in the combined Nicopure Labs/Right to be Smoke-Free Coalition lawsuit has some new facts to consider. Two amicus curiae briefs were filed last week, supporting the vaping industry’s challenge to the FDA deeming regulations. The briefs were accepted by Judge Amy Berman Jackson, who is presiding over the suit in the US District Court for Washington, DC.

Amicus curiae is Latin for "friend of the court"

The court accepted briefs from the Smoke-Free Alternatives Trade Association (SFATA), and a combined brief from TechFreedom and the National Center for Public Policy Research (NCPPR). SFATA is the oldest vapor industry trade group. TechFreedom is a libertarian think tank that opposes regulatory overreach in the technology sector. The NCPPR is a conservative think tank, known best to vapers because of its risk analysis director Jeff Stier, a longtime advocate of tobacco harm reduction and frequent commenter on the FDA’s.

A brief from the Vape A Vet Project supporting the challenge has also been approved and will be filed soon. So will one from the Campaign for Tobacco-Free Kids, which will be in support of the FDA and the deeming regulations.

The FDA's heavy-handed approach to e-cigarettes is an affront to smart governance

Amicus curiae is Latin for “friend of the court,” and an amicus brief is an advisory opinion given to the court from a source that is not a party to the case being decided. According to Ronald Standler, an amicus brief “provides the judges with new information or a different perspective from what the parties provided to the judge.”

There will be no market left

Financial Burden

The SFATA brief focuses on the compliance costs of the deeming rule, and argues that the burden of completing Premarket Tobacco Applications (PMTA) will be far greater than small- and medium-sized vapor companies can bear. They explain that the regulations will inhibit innovation and “will destroy the vapor industry as it is currently constituted.”

SFATA survey respondents reported mean sales revenue of just $307,200 per year. Over half of vape shop revenue comes from e-Liquid sales, and many SFATA survey respondents reported that one of their top-five (5) revenue generators is sale of their own “in-house” e-Liquid formulations. Even assuming moderate PMTA costs (i.e., $1.09 million), regulatory approval for a single e-Liquid formulation would cost more than three times what the typical industry participant makes in yearly revenues. For example, it would cost The Vapor Bar, discussed supra at Page 3, an astonishing $531.92 million to obtain regulatory approval for all e-Liquids in its store catalog at that moderate PMTA cost. And even aside from the money, such a small company could never perform the original testing and research necessary to secure regulatory approval within two years of the Deeming Rule taking effect. Thus, all but the largest industry participants will cease making e-Liquids, and those few that remain will be able to offer far fewer options. And it seems beyond dispute that, at a cost of $1.68 million for a PMTA for every device, there will be no market left for small producers of equipment.

Direct conflict with the standard required by Congress

Not Listening

The TechFreedom/NCCPA brief attacks the FDA’s ignorance and misinterpretation of scientific evidence and its misapplication of the precautionary principle. How, they ask, can the FDA severely restrict a product that scientific consensus shows is far safer than combustible tobacco?

The FDA’s Deeming Rule fails to consider the scientific evidence readily available to the agency regarding the safety and the public health benefits of e-cigarettes. The Deeming Rule is improper under the APA not merely because it fails any manner of scientific analysis, and is therefore arbitrary and capricious, but also because it is in direct conflict with Congress’s intent
to prevent smoking and aid cessation through the Act.

“Instead of developing science-based standards which would reduce harm, the FDA directly admitted it didn’t understand or evaluate the potential benefits or harms of e-cigarettes,” said Jeff Stier in a press release. “Without that science, it relied on the ‘precautionary principle’ standard, in direct conflict with the evidence-based standard required by Congress.”

“Regulations should be promulgated within the constraints of the rule of law, sound policy, and proportionality,” said Daniel Suraci, an attorney working pro bono on behalf of the National Center for Public Policy Research. “The FDA’s heavy-handed approach to e-cigarettes is an affront to smart governance as the regulations are in direct contradiction of the scientific evidence showing the public health benefits of vaping, and push the public back to cancer-causing tobacco products.”

Jim McDonald
I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.
  • Brendan Hughes

    I’m following this case with keen Interest, as what happens here is not only an American issue. This case is a test case for the rest of the world. A loss for the vaping industry will be ammunition for the naysayers worldwide who can point to the FDA as a benchmark.
    So the consequences are further reaching than just the US. A win will start the ball rolling on the demise of tobacco for everyones sake.
    Here in Ireland the government have decided not to add any additional or special taxes in the upcoming budget as they have said (although not officialy) that it is not a tobacco product therefore does not require tobacco taxes long may that hold.

    • Jim McDonald

      Agreed. Good luck with the taxes. Ireland is blessed with one of the smartest and most knowledgable vaping advocates anywhere in Gillian Golden — so you’ve got that going for you.

  • KekTopper

    I would have liked to seen the opposing views too. It matters to see what our opponents are saying to see if they have any validity.

    • Jim McDonald

      I’ll report on the CTFK brief when it’s filed. It hasn’t been yet.